Events

Recall of HeartWare Ventricular Assist System batteries

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Heartware Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2014-RN-00510-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-05-05
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00510-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    Heartware has seen an increase in reported heartware system power management complaints related to both premature battery failure and routine battery handling. premature or unrecognised deterioration of battery capacity or lapses in recommended power management pose a risk to the patient and, although rare, may result in serious injury or death. this action is intended to provide patients and healthcare providers with information to recognise batteries with less than two hours of run time, re-emphasise instruction on actions to take when battery alarms occur and reinforce proper power management. early recognition of premature battery depletion, patient training and close attention to recommended power management practices are crucial to reduce patient risk.
  • Action
    HeartWare is providing information to assist patients and health professionals to monitor battery performance and recognise abnormal behaviour. Health professionals are advised to reinforce the recommended practices for early detection of abnormal battery behaviour and effective power management with their patients. The customer letters identifies the steps to verify that all patients with the HeartWare Batteries are managing their power sources in a safe manner and that batteries are handled in accordance with the Instructions for Use. HeartWare is also advising that complaints will continue to be closely monitored to ensure that the HeartWare System functions as intended and to assess the effectiveness of this field correction. HeartWare will continue to investigate prematurely depleting batteries and will take additional actions as appropriate.

Device

HeartWare Ventricular Assist System batteries
  • Model / Serial
    HeartWare Ventricular Assist System batteriesProduct Code: 1650All HeartWare Battery Serial NumbersARTG Number: 181875
  • Product Classification
    Cardiovascular Devices
  • Manufacturer
    Heartware Pty Ltd

Manufacturer

Heartware Pty Ltd
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    DHTGA